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A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00944567
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : August 15, 2017
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)

Brief Summary:
A non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with conventional approaches.

Condition or disease
Primary Mediastinal B-Cell Lymphoma

Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma
Study Start Date : January 2007
Primary Completion Date : May 2011
Study Completion Date : February 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Primary Outcome Measures :
  1. response rate on PET scanning following initial chemo-immunotherapy

Biospecimen Description:

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient must have histological confirmation of the diagnodis of primary mediastinal diffuse large B cell lymphoma and have a dominant mass within the anterior mediastinum

Inclusion Criteria:

  • Primary mediastinal diffuse large B-cell lymphoma, CD20 positive. Patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
  • No prior treatment of lymphoma. Patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
  • Any stage of disease.
  • Age at least 18 years.
  • Fit to receive chemotherapy with curative intent.
  • Able and willing to give informed consent, and to undergo staging including PET scanning
  • Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.

Exclusion Criteria:

  • Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
  • Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to involvement by lymphoma.
  • Major impairment of renal function (serum creatinine >2x upper normal) or liver function (ASAT/ALAT >2,5 upper normal, total bilirubin >2,5x upper normal), unless due to lymphoma involvement.
  • Known HIV infection. Patients will not be tested routinely.
  • Pregnant or lactating women.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944567

A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
IRCCS Ospedale Oncologico
Bari, Italy
Policlinico S. Orsola Malpighi
Bologna, Italy
Ospedale Oncologico
Cagliari, Italy
Policlinico Careggi
Firenze, Italy
Messina, Italy
Ospedale Niguarda Ca' Granda
Milano, Italy
Ospedale San Raffaele
Milano, Italy
Università di Modena, Policlinico
Modena, Italy
Policlinico S. Matteo
Pavia, Italy
A.O. Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Università di Roma "La Sapienza" - DAI Ematologia
Rome, Italy, 00161
Rozzano, Italy
Ospedale Maggiore San Giovanni Battista
Torino, Italy
Ospedale di Circolo Fondazione Macchi
Varese, Italy
Clinic Hospital Universitari
Barcelona, Spain
Bellinzona, Switzerland, 6500
United Kingdom
Barts & the London NHS Trust
London, United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT00944567     History of Changes
Other Study ID Numbers: IELSG26
EudraCT number 2006-005794-22
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

Keywords provided by International Extranodal Lymphoma Study Group (IELSG):
Primary Mediastinal B-Cell Lymphoma
Positron emission tomography

Additional relevant MeSH terms:
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin